The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Olympic Cfm 6000.
| Device ID | K031149 |
| 510k Number | K031149 |
| Device Name: | OLYMPIC CFM 6000 |
| Classification | Amplitude-integrated Electroencephalograph |
| Applicant | OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Contact | Edward B. (ted) Weiler |
| Correspondent | Edward B. (ted) Weiler OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Product Code | OMA |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-10 |
| Decision Date | 2003-05-14 |
| Summary: | summary |